Compliance Specialist III

Catalent Pharma Solutions•Kansas City, MO

10d•Onsite

About The Position

We have an opportunity for a Compliance Specialist III to join our team. In this role, you will lead investigations and compliance activities to ensure adherence to regulatory standards. You will work closely with cross-functional teams to identify and resolve compliance gaps. This position requires strong attention to detail and a commitment to maintaining high-quality documentation and processes. Shift: Monday - Friday, 1pm - 9pm, Hourly Location: Kansas City, MO 100% Onsite

Requirements

Bachelor’s Degree or equivalent years of experience in a regulated industry; OR High School degree with 5+ years of experience in a regulated industry
Strong computer skills and proficiency in Microsoft Word and Microsoft Excel
Well organized with ability to multitask, work effectively under pressure to meet deadlines, and strong attention to detail

Responsibilities

Lead deviation and investigations using tools such as Fishbone diagrams, 5-Why’s, and other root cause analysis methods
Lead cross-functional teams and meetings to address compliance gaps or concerns
Monitor compliance trends and identify gaps
Assist with review of technical reports supporting cGMP operations
Collaborate with cGMP business units to resolve record inconsistencies
Recommend batch record changes for continuous improvement per approved Standard Equipment Procedures and Standard Operating Procedures
Assist in writing Standard Equipment Procedures and Standard Instrument Procedures for equipment and instruments used by pharmaceutics and operations personnel
Maintain high-quality manufacturing documentation in accordance with regulatory guidance and site Standard Operating Procedures
Participate in assigned improvement projects
Maintain compliance with all assigned training requirements
Perform other duties and special projects as assigned